CClinicalTrials.gg
Status unknownNCT03285282Updated Sep 18, 2017

Evaluation of Thoracolumbar Interfascial Plane Block for Postoperative Analgesia After Herniated Lumbar Disc Surgery

An Early Phase 1 interventional study of Thoracolumber interfascial plane block in Postoperative Analgesia After Disc Surgery, sponsored by Ain Shams University. Status unknown at 1 site in Egypt. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2017-09-18.

Sponsored by Ain Shams University · Early Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Early Phase 1
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
21 Years to 60 Years
Sex
All
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Study summary

Several regional anesthesia have been shown to improve postoperative outcomes in many studies. The transversus abdominis plane (TAP) block provides anesthesia to the abdominal wall by introducing local anesthetic to the anterior rami of the spinal nerve roots. This work evaluates the analgesic effects gained after performing thoracolumbar interfacial plane block (analogous to the TAP block but intended for the back) which targets the sensory component of the dorsal rami of the thoracolumbar nerves in patients undergoing back surgeries.

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Conditions studied

  • Postoperative Analgesia After Disc Surgery

Browse trials for

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Who can participate

Ages eligible
21 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • patients with ASA 1 or 2 aged between 21years old up to 60 years old of both sex scheduled of back surgery

Exclusion criteria

Exclusion Criteria:

  • Exclusion criteria will be patients refusal or inability to give an informed consent , history of relevant allergy to any of the drugs used in the procedure , previous lumbar spine surgery or back surgery with planed spinal fixation.
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Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    Intervention

    Thoracolumber interfascial plane block

    Procedure: Thoracolumber interfascial plane block

  • No intervention
    Control

Interventions

  • ProcedureThoracolumber interfascial plane block

    Thoracolumber interfascial plane block versus placebo

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What researchers measure

Primary outcomes

  1. Visual Analogue Score

    Time frame: 24 hrs postoperative

Secondary outcomes

  1. Total morphine consumption

    Time frame: 24 hrs postoperative

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Study locations

1 of 1 sites recruiting
  • Faculty of medicine
    Cairo, 1234, Egypt
    • Waleed Abdalla, MD · Contact
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT03285282
Lead sponsor
Ain Shams University
Responsible party
Mona Ammar (Lecture of anesthesia,intensive care and pain management, Ain Shams University) — Principal investigator
First posted
Sep 18, 2017
Start date
May 8, 2017
Primary completion
Oct 2017 (estimated)
Completion
Nov 2017 (estimated)
Last update
Sep 18, 2017

Study contacts

Mona Ammar, MD
Contact
Mona_3mmar@Hotmail.com
01006236620
Mohamed Taeimah, MD
Contact

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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